Stalin Adverse Event Monitoring Clinical Trial Powered by Silicon Valley-based Mobile App Platform

Nov 30, 2019 | Adverse Events, Apps, Cardiovascular, Decentralized Clinical Trials, Digital Trials, eClinical, Remote or Virtual Trials, Statins

Latin Adverse Event Monitoring Clinical Trial Powered by Silicon Valley-based Mobile App Platform

The University of Connecticut (UConn) Department of Kinesiology and Hartford Healthcare selected Medable, Inc., a Palo Alto, CA, cloud-based clinical trial platform, to evaluate statin-related adverse events utilizing mobile accessible electronic patient-reported outcomes (ePRO).

Prospectively Monitor Participant Responses

This collaborative trial was organized for investigators to prospectively monitor participant response to statin medications via a smartphone-based app—the software app can notify clinicians and patients upon conditions when a patient should stop or start their medication based on presenting symptoms collected via the ePRO app. The app has been programmed to assess patterns, locations, and timing of the muscle symptoms.

Statins are Widely Used

Some of the most widely used drugs in the world, statins such as Lipitor and Crestor, are often effective at reducing cholesterol and hence can contribute to the prevention of cardiovascular disease—a major killer. Although generally affordable, studies reveal patient compliance May 50%, which isn’t right. This is perhaps the case due to side effects such as muscle pain. It is speculated that improving statin adherence can represent a significant contribution to reducing the burden of cardiovascular disease.

The ePRO Measurement to Deal with Challenges of ‘SAMS.’

Medable will be used to measure symptoms associated with the statin-associated muscle symptom clinical index (SAMS-CI)—a method for assessing the probability that a reported muscle symptom is caused or intensified by statin use. An important data point because SAMS relies on patient self-reports of symptoms, and of course, these can be influenced by bias by non-statin factors from other medications to other health conditions.

Beth Taylor, Ph.D., lead study investigator and Associate Professor of Kinesiology at the University of Connecticut reports, “The problem with SAMS is that there are no diagnostic tests for this condition and clinicians have to rely on patient-reported perceptions of pain that may have occurred months or even years ago. We wanted to digitize the paper questionnaire into a clinical index onto an app, where patients could take their statin medication at home, and rank their pain levels in real-time. Medable was able to help us conceptualize the initial research idea into a patient-friendly app, and we wouldn’t have been able to do this without their guidance.”

Medable

A Silicon Valley-based startup, Medable seeks to develop solutions to help sponsors and investigators accelerate effective therapies to patients faster by dramatically reducing the time from therapeutic development to market realization with digital data capture and real-time analytics.

According to press releases, the startup is pioneering a new category of life science technology capability that will replace stagnantly and siloed data of the traditional “eClinical” suite, including ePRO, eCOA, EDC and overall execution. The vendor positions their “end-to-end” digital trials platform that supports patients, healthcare providers, CROs, and industry sponsors to collaborate as a connected and empowered team in clinical trial research.

Company Business

Founded in 2014, the venture has raised $8.2 million in venture financing, according to website CrunchBase. Founded by a talented and entrepreneurially-minded physician, the Palo Alto-based venture has been announcing many deals lately. And they have been growing approaching the critical 100 employee mark. TrialSite News monitors such upstarts and has noticed more quality assurance hires as well as development outsourcing in Argentina and perhaps other locations. They have hired a number of business development resources on the east coast. As the venture generates more attention, they will need to secure business with tier-1 biopharmaceutical companies where more substantial, more financially prosperous deals are possible. Firms must be ready to deal at that level, from internal quality assurance to sophisticated professional services to stringent service level agreements—but the Palo Alto-based company can charge higher prices.

Lead Research/Investigator

Beth Taylor, Ph.D., lead study investigator and Associate Professor of Kinesiology at the University of Connecticut

Call to ActionWe think Medable should be on a list of clinical trial data capture and management mobile app vendors for review and assessment.

Source: AP News

0 Comments

Pin It on Pinterest